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Maquet Cardiovascular Recalls
252 recalls on record · January 16, 2013 to July 22, 2026 · Medical Devices
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 48002 Bridge Kit Material: 709000444
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 25502 1/4 Better Bladder Material: 709000434
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 9410 Lurie Chldns Small 1/4 Material: 709000430
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 9409 Lurie Chlds Large 3/8 Material: 709000428
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-T 5220 UAB Hospital Accessory Material: 709000426
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 57000 Rotaflow Pack Material: 709000424
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 27602 709000417 Adult Custom Pack Material: 709000417
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 36507 Accessory Pk Mercy Material: 709000390
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-T 51502 Ochsner ECC Adult Pack Material: 709000385
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 25501 3/8" Better Bladder Pack Material: 709000370
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 4917 Mercy Medical Versa-Pack Material: 709000368
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-T 8030 4 in High Flow Pigtail Material: 709000366
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 5914 TCH ¿ Inch Change Kit Material: 709000334
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 5915 TCH 3/8 Inch Change Kit Material: 709000280
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 52301 ¿ Sash & Accessory Pack Material: 709000266
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 53400 Adaption Pack Material: 709000213
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 8506 Transport Pack Material: 709000146
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-T 46201 Small Pediatric Cardiac Surge Material: 709000133
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-T 52360 Cardioplegia Pack Material: 709000127
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 51502 Ochsner ECC Ancillary Pack Material:709000115
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 51501 Ochsner ECC Pack Material:709000113
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-TOP 28903 Adult ECC Pack Material: 709000093
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 50903 Custom ECC Pack-Pedriatric Material: 709000078
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 28906 1/4" with Bridge Ancillary P Material: 709000072
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 49103 ECC Pack 0 No Bladder Material: 709000058
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-T 30914 ECC Pump Pack 1/4" Material: 709000011
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-T 2302 Pediatric Cardiac Surgery Pack Material: 709000006
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BO-T 2303 Small Adult Cardiac Surgery Material:709000004
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 8208#3/8 inch ECC Pack Material: 701068798
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured
June 5, 2019Medical DevicesFDA
Maquet Cardiovascular, LLC recalls Maquet Getinge-BEQ-TOP 35503 SGD Pack Material: 701068797
Hazard: Custom Tubing Sets for Extracorporeal Circulation (ECC)-During sterilization, the closed stopcock/non-vented cap configuration may prevent the flow of humidity/ethylene oxide gas into the fluid-path between the closed port and the non-vented cap therefore the Sterility Assurance Level (SAL) of the stopcock ports cannot be assured